Medication info
Samchundang Dutasteride Soft Capsules 0.5mg

Samchundang Dutasteride Soft Capsules 0.5mg

Prescription medicationSoft capsuleOral
Ingredient · strength
Dutasteride›0.5mg / 1 capsule
Manufacturer / importer
Samchundang Pharmaceutical Co., Ltd.
Appearance
Opaque, cloudy yellow oblong soft capsule containing a colorless transparent solution
Packaging
30 capsules (10 capsules/PTP x 3)
Approval status
Active

MFDS item code 201507472 · Approved 2015.10.30 · Insurance code 651204460

Summary

Main use
Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Swallow the capsule whole without chewing or breaking it. Exposure to the capsule contents may cause irritation of the oropharyngeal mucosa. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or in elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on administration of this medicine to these patients.

Ingredients

Manufacturer
Samchundang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and androgenetic alopecia in adult men

  • Benign prostatic hyperplasia
  • acute urinary retention
  • androgenetic alopecia
View approved original text

This medication improves the symptoms of benign prostatic hyperplasia, reduces the risk of acute urinary retention, and lowers the likelihood of requiring surgery related to prostatic hyperplasia. Additionally, it is effective in treating androgenetic alopecia in adult males. Overall, it is used to enhance prostate health and improve hair loss.

How to take

Adult dose

The recommended dose of this medicine is 1 capsule (0.5mg) once daily. Swallow the capsule whole without chewing or breaking it. Exposure to the capsule contents may cause irritation of the oropharyngeal mucosa. This medicine may be taken with or without food. No dosage adjustment is necessary in patients with renal impairment or in elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on administration of this medicine to these patients.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not touch or handle this medication. If the capsule is broken and comes into contact with the skin, wash thoroughly with soap and water immediately. This medication is not to be used in children under the age of 18. Additionally, individuals with allergies to this medication or similar ingredients should not use it. Adult males who plan to conceive should use this medication cautiously after consulting a physician, as it may affect fertility. Patients with severe urinary tract issues or liver function problems should use this medication with caution and should be monitored closely per physician instructions, if necessary. Since this medication is metabolized in the liver, special attention is required for patients with certain liver function disorders or those on strong CYP3A4 enzyme inhibitors for an extended period. During treatment with this medication, erectile dysfunction, reduced libido, and ejaculatory disorders may occur, and these symptoms may persist even after discontinuation of the treatment. Other reported side effects include gynecomastia, headaches, gastrointestinal discomfort, dizziness, and mood depression. This medication is used for the treatment of benign prostatic hyperplasia or androgenetic alopecia, and regular prostate cancer screenings should be performed before and during treatment. PSA levels in the blood may decrease, so caution is needed when interpreting test results. Blood donation is prohibited during treatment with this medication, and a minimum of 6 months should pass after the last dose before donating blood. This medication is contraindicated for women and children, especially pregnant women, as it may seriously affect the fetus and should never be used. In the case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment. Store in a place out of reach of children and in the original container to maintain the quality of the medication. This medication is not known to affect the ability to drive or operate machinery; however, caution should be exercised if adverse reactions occur.

Side effects

  • Erectile dysfunction
  • decreased libido
  • ejaculation disorders
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • testicular pain
Show 72 more
  • testicular swelling
  • rash
  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressive mood
  • alopecia
  • hirsutism
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thrombotic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dystonia
  • vomiting
  • colon polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • pharyngitis
  • appendicitis
  • fractures
  • viral infections
  • fatigue
  • increased SGPT
  • increased SGOT
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disorders
  • folliculitis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory disturbances
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • taste disorder
  • telangiectasia
  • visual disturbances
  • fatty liver
  • thirst
  • abnormal urination
  • hematuria
  • abnormal semen

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to prevent air ingress, and it is advisable to keep the temperature below 30 degrees. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Opaque, cloudy yellow oblong soft capsule containing a colorless transparent solution

Package unit

30 capsules (10 capsules/PTP x 3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.